23 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HSINER CPAP SILICONE NASAL MASK SIZE XS/PETITE HSINER NASAL PILLOW MASK HSINER INFANT CPAP CANNULA
FDA 510(k)
FDA Class 2
·Anesthesiology
Unity Total Knee System
FDA UDI
CORIN LTD·05056139243431·UNITY KNEE™ PS-C INSERT - Size 9 x 20mm
ArgenPMMA Multi 98x14-D3
FDA UDI
ARGEN CORPORATION, THE·D818120920·Crown And Bridge, Temporary, Resin
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587P1209200·12mm PLIF Implant 9mm Wide 20mm Length
ATEC 1209-20
FDA UDI
Hologic, Inc.·15420045504905·12G (2.7MM) X 9.5CM, 20MM HANDPIECE
WeightRight®
FDA UDI
DIVERSATEK HEALTHCARE, INC.·00816734020739·Tungsten-Filled Hurst Esophageal Dilator, 20 Fr...
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587P12092070·12mm PLIF Implant 9mm Wide 20mm Length 7 Degrees
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B167311209200·
MESA II OXYGEN CONCENTRATOR MODEL: T2000 SERIES
FDA 510(k)
FDA Class 2
·Anesthesiology
COZART RAPISCAN ORAL FLUID DRUG TEST - OPIATE/METHADONE
FDA 510(k)
FDA Class 2
·Clinical Toxicology
NA
FDA UDI
STRYKER CORPORATION·04546540494764·SD/PD Series MIS Medium Straight Attachment
ATEC BIOPSY SYSTEM
FDA Adverse Event
Malfunction
·HOLOGIC, INC.·Product code KNW·September 14, 2009
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 16, 2025
AMPLATZER TORQVUE DELIVERY SYSTEM
FDA Adverse Event
Injury
·AGA MEDICAL CORPORATION·Product code DQY·July 3, 2012
AMISTEM H HA COATED LAT STEM SIZE 2
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·February 14, 2018
LIFEPAK(R) 20E DEFIBRILLATOR/MONITOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC·Product code MKJ·May 20, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 26, 2014
COULTER® LH 780
FDA Adverse Event
BECKMAN COULTER INC·Product code GKZ·June 13, 2011
PROXIMATE*HCS HEMORR CIR STAPL
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 27, 2018
KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 5 / Adult Silicone King LAD¿ Patient Size: >70kg Product Usage: Laryngeal airway
FDA Enforcement
Class II
·Terminated·King Systems Corp.·November 28, 2012